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After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
On April 27, 2018, the US Pharmacopeial Convention (USP) announced it was not moving forward with its biologics naming proposal, General Notices Section 2.20, published in the Pharmacopeial Forum, and it will not address nomenclature issues without further collaboration with FDA and other stakeholders. The decision was made in response to comments received by FDA.
USP stated in a press release that it will focus on developing performance standards applicable to monoclonal antibodies or cell therapies and developing standards for raw materials. The organization will also work to “ensure alignment with FDA on the use of the term ‘with sensor’ in approved product names, for drug therapies with sensor technology that verifies when a patient has taken their medication.”
“USP's biologics performance standards can help manufacturers ensure the quality of their products and are part of the overall safety net that helps protect our medicine supply in the United States,” said Jaap Venema, PhD, chief science officer, in the release.